Kornimate/medical-research-clean huggingface dataset:
liq-nol efficacy in pediatric patients with down syndrome

Conditions: Down Syndrome

Summary: the purpose of this study is to measure the effects of liq-nol supplementation on language production using the clinical evaluation of language fundamentals test, language sampling using the mean length of utterance test, and speech articulation using the goldman-fristoe test of articulation.

this is a randomized, double-blind, placebo-controlled clinical study of coq efficacy in a crossover design. patients will be screened, enrolled, and studied in the outpatient clinic of the thomas center for down syndrome at cchmc. all patients will be randomly assigned to either a liquid product (liq-nol®) and an identical placebo liquid. study drug and placebo will be administered twice a day (morning and evening).

Eligibility criteria:
inclusion criteria: * patients ranging from 6.0 years to 16 years of age. * patients will have proven trisomy 21. * females, incapable of bearing children or capable of practicing adequate birth control methods. abstinence will be acceptable. * written informed consent will be obtained from parents of all subjects prior to enrollment. verbal assent will be obtained from all patients with ds who have sufficient decision making ability and are at least 11 years old. exclusion criteria: * patients who have insufficient mental and/or motor capacity to complete testing measures. * patients less than 6 years or older than 16 years of age. * patients receiving coq supplementation within one month prior to the study. * patients with evidence of disease which may adversely affect coq absorption, e.g. chronic diarrhea or inflammatory bowel disease. * patients participating in other research studies or having exposure to investigational drugs within one month prior to this study. * females, capable of bearing children, who are unsure of their pregnancy status or not practicing adequate birth control methods. * females who are pregnant. * patients with a known allergy to coq. * patients receiving drug treatment which is know to affect coq, e.g. cholesterol-lowering drugs such as "statins".

Keywords: down syndrome coenzyme q10 language function behavior
motor control exercise program for pregnant women with a history of lumbopelvic pain

Conditions: Lumbopelvic Pain

Summary: this study protocol was designed to establish the feasibility of conducting a motor control exercise program with pregnant women presenting a history of lumbopelvic pain (lbpp) in order to reduce lbpp occurrence or limit its intensity. this randomized controlled trial also aims to preliminary assess the effectiveness of the program. to do so, 40 pregnant women with a history of lbpp will be recruited and randomly allocated to one of 2 groups: control (20 participants) or intervention (20 participants). the control group will receive standard care, including basic information on what to do when suffering from lbpp. the intervention group will participate in a weekly 40-minute group session and two more 40-minute weekly home exercise sessions. the motor control exercise program will be designed to target strengthening of the lumbo-pelvic-hip core muscles in order to improve stabilization and protection of the spine and pelvis. participants of this group will also receive standard care. adequate prevention and treatment of lbpp, experienced by women during pregnancy, should help reduce lbpp occurrence or limit its intensity during pregnancy.


Eligibility criteria:
inclusion criteria: * being pregnant of one fetus * being ≤ 20 weeks pregnant * presenting a history of lumbopelvic pain exclusion criteria: * inflammatory rheumatic disease * infectious disease * neuromuscular disease * vascular disease * connective tissue disease * severe disabling pain * neurologic signs and symptoms

Keywords: physical activity non-invasive treatment
phase ib study to evaluate rad1901 on the availability of estrogen receptor binding sites in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to visualize and quantify er-binding sites during treatment with elacestrant (rad1901)

the purpose of this study is to visualize and quantify er-binding sites during treatment with elacestrant (rad1901) using 16α-18f-fluoro-17β-estradiol (fes) positron emission tomography (pet) imaging

Eligibility criteria:
key inclusion criteria: 1. patients with histologically-proven, er-positive, human epidermal growth factor receptor 2 (her2)-negative, locally advanced, inoperative, and/or mbc 2. tumor progression after ≥ 6 months of at least 1 line of hormonal systemic treatment (serm, serd, or aromatase inhibitor) in the metastatic setting 3. measurable disease according to response evaluation criteria in solid tumours (recist) criteria v1.1 or clinically evaluable disease 4. greater than or equal to 18 years of age 5. patients must be post-menopausal 6. life expectancy \>3 months key exclusion criteria: 1. greater than 3 lines of endocrine therapy for metastatic disease. 2. prior anti-cancer treatment or investigational drug therapy within the following windows: 1. tamoxifen or fulvestrant therapy \< 42 days before 1st 18fes-pet scan 2. any other anti-cancer endocrine therapy \< 14 days before 1st dose of study drug 3. any chemotherapy \< 28 days before 1st dose of study drug 4. any investigational drug therapy \< 28 days or 3 half-lives (whichever is longer) prior to the 1st dose of study drug 2. patients with untreated or symptomatic central nervous system (brain) metastases 3. patients with known endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding, or cysts
the role of vitd in rehabilitation of idiopathic adolescent scoliosis

Conditions: Scoliosis; Adolescence

Summary: the purpose of this current prospective study is to determine the role of vitamin d in the development and restoration of spinal deformities in adolescence.

the investigator will record the medical history of each patient and information such as age, body size (weight, height) and body mass index (bmi = kg / m \^ 2). girls will also be given the time of appearance of menstruation, a factor that needs to be evaluated because the growth of the skeleton continues three years after its appearance. patients will be subjected to adam's test, x-ray's and as well as lateral bending radiographs.in the first contact with each patient, will be evaluated bone density measured by dexa as well as haematological testing including pth, alkaline phosphatase (alp), calcium (ca), phosphorus( p ), calcitonin and, of course, vitamin d (total and metabolite 25 (oh) d). each patient's follow-up will be completed in two years by a clinical examination every six months and a clinical, laboratory and radiological examination per year. patients will be divided into two groups. in a group with patients with normal 25 (oh) d and in a second group with patients with low levels of 25 (oh) d. members of the second group will receive substitution treatment with an appropriate formulation. the results will be collected and evaluated using statistical programme.

Eligibility criteria:
inclusion criteria: * idiopathic adolescent scoliosis * risser sign \<3-4 exclusion criteria: * neuromuscular diseases * metabolic disease * liver, lung, thyroid and parathyroid gland disorders.
bioflow-iii hungary satellite registry

Conditions: Coronary Artery Disease; Myocardial Ischemia

Summary: this registry is a clinical post-market evaluation of the orsiro less in subjects requiring coronary revascularization with drug eluting stents (des)

for the majority of coronary artery disease (cad), treatment with percutaneous transluminal coronary angioplasty (ptca) provides high initial procedural success. however, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. the reported incidence of restenosis after ptca ranges from 30%-50%. such rates of recurrence have serious economic consequences. bare metal stents (bms), designed to address the limitations of ptca, reduced the angiographic and clinical restenosis rates in de novo lesions compared to ptca alone and decreased the need for cabg. bms substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. the invention of drug eluting stents (des) significantly improved on the principle of bms by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. the introduction of des greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to bms with systemic drug administration. these advantages and a lower cost compared to surgical interventions has made des an attractive option to treat coronary artery disease. this observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the orsiro drug eluting stent system in an all-comers patient population in daily clinical practice

Eligibility criteria:
inclusion criteria: * symptomatic coronary artery disease * subject has signed informed consent for data release * subject is geographically stable and willing to participate at all follow-up assessments * subject is ≥ 18 years exclusion criteria: * subject did not sign informed consent for data release * pregnancy - known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for pci, stainless steel, sirolimus or contrast media * planned surgery within 6 months of pci unless dual antiplatelet therapy will be maintained * currently participating in another study and primary endpoint is not reached yet

Keywords: international multicenter observational registry orsiro drug eluting stent (des) stenting treatment of coronary artery disease coronary revascularization percutaneous coronary intervention stemi nstemi ischemia subgroups acute myocardial infarction diabetes small vessels chronic total occlusion (cto)
total lifestyle coaching pilot study (tlc)

Conditions: Obesity; Weight Loss; Telemedicine

Summary: the investigators aim to develop, pilot and evaluate a new "total lifestyle coaching" (tlc) program, that will address both information and behavior-change aspects of nutrition education for patients whose body mass index (bmi) exceeds 25.

this is a single-arm pilot study of patients at the revere healthcare center with a bmi greater than 25. the intervention consists of a single in-person assessment with a dietician followed by telephone coaching sessions addressing nutrition, sleep, stress-reduction skills, and physical activity over the course of 6 months. study team assessed anthropomorphic, demographic, and behavioral measures prior to the initial dietician assessment and at study completion (6 months following enrollment). semi-structured exit interviews assessing participants' experiences in the program were also conducted following program completion.

Eligibility criteria:
inclusion criteria: 1. age 21 and older 2. body mass index (bmi) exceeds 25 3. speaks english 4. has access to a telephone 5. able to come into mgh-revere health center for at least four face-to-face meetings over a six month period. 6. overweight (bmi exceeds 25)
comparison of oral morphine versus nasal ketamine spray with chitosan in cancer pain outpatients

Conditions: Cancer: Breakthrough Pain; Cancer: Extreme Pain on Movement

Summary: 34 adult (\>18 years) cancer pain outpatients with opioid base therapy because of pain and breakthrough pain or extreme pain on movement will be included in this prospective, randomized, double-blind crossover study. over a period of 3 weeks patients will go through 3 treatment arms, each one lasting one week: group a receives morphine drops and placebo spray, group b receives ketamine/chitosan spray nasal and placebo drops and group c receives morphine drops and ketamine/chitosan spray nasal. primary endpoint is time to onset of action of intranasal ketamine compared with morphine drops. secondary endpoint is the median numeric rating scale (nrs) improvement after using the spray or morphine or the combination of ketamine spray and morphine drops.


Eligibility criteria:
inclusion criteria: * cancer pain in outpatients with: * opioid based therapy due to pain * breakthrough pain or * extreme pain on movement * age \>= 18 years exclusion criteria: * patients unable to give written informed consent * patients unable to understand how to handle and document the use of the study medication * known drug allergies or intolerance to ketamine * known drug allergies or intolerance to morphine * known allergy to crustacea or chitosan * patients using snuff at a regular basis * recreational drug addiction or abuse * serious intranasal or epipharyngeal problems (septum wall defects, cancer) * mental/psychiatric disorder * patients with renal failure (clearance \< 30 ml/min) * pregnancy and breast feeding mothers * patients not understanding german * patient having arterial hypertonia with measured values \> 180/95
wrist extensor mep up-conditioning for individuals with incomplete spinal cord injury

Conditions: Spinal Cord Injuries; Quadriplegia

Summary: the purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. a transcranial magnetic stimulator (tms) is used for examining brain-to-muscle pathways. this stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. the target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. it is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm. it is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (sci). this study requires 30 visits, and each visit will last approximately 1.5 hours.


Eligibility criteria:
inclusion criteria: 1. a history of injury to spinal cord at or above c6 2. neurologically stable (\>6 mo post sci) 3. medical clearance to participate 4. weak wrist extension at least unilaterally 5. expectation that current medication will be maintained without change for at least 3 months. stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted. in participants with bilateral wrist extension weakness, the more severely impaired arm is studied. exclusion criteria: 1. motoneuron injury 2. medically unstable condition 3. cognitive impairment 4. a history of epileptic seizures 5. metal implants in the cranium 6. implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant) 7. no measurable mep elicited in the ecr 8. unable to produce any voluntary ecr emg activity 9. extensive use of functional electrical stimulation to the arm on a daily basis 10. pregnancy (due to changes in posture and potential medical instability).
pet-mri in diagnosing patients with colon or rectal cancer

Conditions: Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IIA Colon Cancer; Stage IIA Rectal Cancer; Stage IIB Colon Cancer; Stage IIB Rectal Cancer; Stage IIC Colon Cancer; Stage IIC Rectal Cancer; Stage IIIA Colon Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer

Summary: this pilot clinical trial studies positron emission tomography (pet)-magnetic resonance imaging (mri) and pet-computed tomography (ct) as diagnostic imaging in patients with colon and/or rectal cancer. new diagnostic imaging procedures, such as pet-mri, may help find and diagnose rectal cancer or recurrence of colorectal cancer

primary objectives: i. to test the diagnostic performance of pet- mri in the staging of preoperative high-grade rectal cancer patients, defined by t3 stage or higher or n1 stage or higher or presence of metastasis, that are referred to pet-ct and mri. ii. to test the diagnostic performance of pet-mri the follow up of colorectal cancer patients that are referred to pet-ct with or without a diagnostic mri request by their physicians. secondary objectives: i. to test different attenuation correction mr sequences and novel diagnostic mr sequences. outline: patients undergo fludeoxyglucose f 18 pet-ct and pet-mri.

Eligibility criteria:
inclusion criteria: * either having a t3 (the cancer has grown through the muscularis propria and into the outermost layers of the colon or rectum but not through them) or higher, node positivity or metastatic lesion in the context of rectal cancer or being studied for colorectal cancer follow up, independent of the renal function * pet-ct should be requested by a referring physician; in the case of having an mr requested as well, it will be reported from the mri images generated in the pet-mri * stable physical medical conditions to undergo a mri * informed consent must be given and signed prior to study enrollment exclusion criteria: * refuse to give and/or sign the informed consent * subjects who do not meet the above mentioned inclusion criteria * subjects who have a pacemaker * subjects who have a metallic prostheses either in the pelvis or in the abdomen that will interfere with the mr imaging of that anatomical area * subjects who suffer from claustrophobia * pregnant women * cognitive impairment that affects the subject's ability to give consent
ono-4538 study in patients with advanced non-small cell lung cancer

Conditions: Advanced Non-small Cell Lung Cancer (NSCLC)

Summary: the objective of the study is to investigate the efficacy and safety of ono-4538 in subjects with stage iiib/iv or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.


Eligibility criteria:
inclusion criteria: 1. male or female ≥ 20 years of age 2. histologically or cytologically confirmed non-small cell lung cancer 3. diagnosis of nsclc in stage iiib/iv unsuited to radical radiotherapy according to uicc-tnm classification (7th edition) or recurrent nsclc 4. has at least one measurable lesion, as defined by the recist guideline (version 1.1) exclusion criteria: 1. current or prior severe hypersensitivity to another antibody product 2. multiple primary cancers

Keywords: ono-4538 advanced non-small cell lung cancer (nsclc) nivolumab
assessment of the immunogenicity and safety of pentaxim™ in philippines

Conditions: Diphtheria; Tetanus; Polio; Pertussis; Haemophilus Influenzae Type B

Summary: the present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of aventis pasteur's dtacp-ipv//prp\~t combined vaccine (pentavac™/pentaxim), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the who epi primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and hib vaccines. who epi vaccination schedules for hepatitis b (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to hbsag seronegative mothers. to assess the safety of pentaxim.

open, randomized, multicentric, controlled trial. infants will be randomly allocated in one of the two study groups as follows: group a: 212 subjects will receive the pentaxim™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis b vaccine at 0, 6 and 14 weeks of age. group b: 212 subjects will receive the pentaxim™ and the recombinant 10 µg hepatitis b vaccines at 6, 10 and 14 weeks of age. all infants included in the study will receive a booster dose of pentaxim™ vaccine at 18-19 months of age.

Eligibility criteria:
inclusion criteria: * informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention * healthy male or female newborn * age ranging from birth to 48 hours of life (included) * birth weight \>2.5 kg and gestational age \>37 weeks * born to hbs antigen-negative mother exclusion criteria: * known previous therapy of the mother with cadaveric pituitary derived human growth hormone * infant presently enrolled or scheduled to be enrolled in another clinical trial * infant with moderate or severe illness, mainly infectious diseases * infant with fever (rectal temperature \> 38°c or axillary temperature \> 37.5°c) * infant with severe congenital defects or abnormalities * uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. * known immunological deficiency (including a known hiv seropositive mother) * administration of vaccine since birth (other than bcg) * previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)

Keywords: pentaxim
a clinical trial of the use of remote heart rhythm monitoring with a smartphone after cardiac surgery

Conditions: Atrial Fibrillation and Flutter; Atrial Fibrillation; Postoperative Complications; Arrhythmia

Summary: the objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (poaf) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.

a predefined subgroup analysis of the outcomes described below will be performed in the following subgroups: * subjects not on anticoagulation drug therapy (for a planned duration of \>45 days) at discharge. * subjects with no history of af prior to surgery and no poaf lasting \>24h in hospital. * subjects with a chadsvasc score ≥ 4 or a chadsvasc score ≥ 2 with at least one additional risk factor associated with the risk of developing poaf. additional risk factors include: * chronic obstructive pulmonary disease * sleep apnea * impaired renal function * left atrial enlargement * elevated body mass index * combined cabg with valve repair or replacement

Eligibility criteria:
inclusion criteria: * subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve) * subject provides informed consent * subject understands and agrees to comply with planned study procedures. * subject is able to perform heart rhythm measurement using the fibricheck application at home. exclusion criteria: * pacemaker dependent heart rhythm * permanent af/aflutter or af/aflutter present at the time of inclusion * insufficient cognitive or comprehensive level of dutch to participate to the trial. * no smartphone available at home.

Keywords: atrial fibrillation digital health artificial intelligence cardiac surgery postoperative atrial fibrillation (poaf)